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Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Primary Purpose

Thyroid Neoplasms, Carcinoma, Thyroid Cancer

Status

Terminated

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Bevacizumab

About this trial

This is an interventional treatment trial for Thyroid Neoplasms focused on measuring adjuvant, Anaplastic thyroid cancer

Eligibility Criteria

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Inclusion Criteria:

cytologically or histologically verified anaplastic thyroid cancer
completed standard therapy
operated with R0 or R1 surgery
Performance Status 0-2 (if pulmonary mets PS 0-1)
normal wound healing
neutrophils > 1,5 million/ml
platelets > 100 million/ml
bilirubin < 2 ULN
creatinin < 150mikromol/L

Exclusion Criteria:

PS 3-4 (if pulmonary mets 2-4)
R2 resection of primary tumor

Sites / Locations

Jubileumskliniken, Sahlgrenska universitetsjukhuset
Dep of Oncology, Lund University Hospital
Karolinska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy

Arm Description

Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Response rate

Full Information

NCT ID

NCT00804830

First Posted

December 8, 2008

Last Updated

August 24, 2018

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT00804830

Brief Title

Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Official Title

Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

lack of response

Study Start Date

April 2008 (Actual)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that angiogenesis is very important for these tumors to progress. Preclinical data is suggesting this. This is why we we prospectively want to treat these patients with avastin (and doxorubicin). However, local control is of major concern. Therefore, patients are initially treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this study.

Detailed Description

Patients with Anaplastic Thyroid Cancer have a poor prognosis. We will treat the patients initially with our standard radiochemotherapy, which consists of doxorubicin 20mg fixed dose/week and hyperfractionated radiotherapy 1,6 Gy twice daily up to 46 Gy in total. The first week during radiotherapy, they will also receive Avastin 15mg/kg. 1-2 weeks after radiotherapy patients will undergo surgery of their primary tumor. After this "standard" therapy patients can be included in this study. Treatment is 20 mg fixed dose doxorubicin q1w and avastin 15mg/kg q3w. Treatment will continue maximum 6 months or until progress or until intolerable side effects occur.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Neoplasms, Carcinoma, Thyroid Cancer, Metastatic Cancer

Keywords

adjuvant, Anaplastic thyroid cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

chemotherapy

Arm Type

Experimental

Arm Description

Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Intervention Description

Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

2-5 years

Secondary Outcome Measure Information:

Title

Response rate

Time Frame

2-5 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: cytologically or histologically verified anaplastic thyroid cancer completed standard therapy operated with R0 or R1 surgery Performance Status 0-2 (if pulmonary mets PS 0-1) normal wound healing neutrophils > 1,5 million/ml platelets > 100 million/ml bilirubin < 2 ULN creatinin < 150mikromol/L Exclusion Criteria: PS 3-4 (if pulmonary mets 2-4) R2 resection of primary tumor

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Tennvall, MD, PhD

Organizational Affiliation

Dep of Oncology, Lund University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jubileumskliniken, Sahlgrenska universitetsjukhuset

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Dep of Oncology, Lund University Hospital

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

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